Power Morcellator Sales Suspended
Ethicon responded to the FDA’s early 2014 warning with the following statement:
In light of an April 17 FDA public safety communication, Ethicon has suspended sales, distribution, and promotion of its morcellation devices while the role of morcellation with symptomatic fibroid disease is redefined by the FDA and the medical community.
– Ethicon statement, April 30, 2014
It is important to note that Ethicon’s announcement does not constitute a power morcellator recall, and that power morcellators remain in use at hospitals around the country. According to the company, they are waiting for the FDA to provide further clarification regarding the use of power morcellation in fibroid surgeries. The Ethicon products included in the sales suspension are:
- Gynecare Morcellex Tissue Morcellator
- Morcellex Sigma Tissue Morcellator System
- Gynecare X-Tract Tissue Morcellator
Other manufacturers of power morcellators include Blue Endo, LiNA Medical, Lumenis, Karl Storz, Olympus, and Richard Wolf.
Hooman Noorchashm, MD, a cardiothoracic surgeon at Brigham and Women’s Hospital in Boston, MA, is a vocal critic of J&J’s reaction to the FDA announcement. His wife, Amy Reed, MD, an anesthesiologist, underwent a hysterectomy with power morcellation in October of last year, which resulted in a uterine leiomyosarcoma and in turn worsened her prognosis. Noorchashm and Reed argue that the FDA’s actions aren’t enough, and the devices should be completely recalled.
FDA Involvement With Power Morcellators
To further their understanding of the risk of laparoscopic power morcellators to disseminate undetected cancer beyond the uterus in women, and in order to establish information regarding the appropriate use of these medical devices, the FDA has ordered several actions. 5
- Product labeling on power morcellators used during laparoscopic hysterectomy and myomectomy should be reviewed by their manufacturers to ensure the labels supply adequate information regarding the risks posed to unsuspecting patients and their providers.
- Information from patient and health care provider testimonies, event reports, surgical professionals, manufacturers, etc., will be collected to continue the investigation regarding the safety of power morcellators.
The FDA convened an Advisory Committee in July 2014 to address the use and potential risks of power morcellation, which featured testimony from health professionals as well as members of the public affected by power morcellators. While a consensus was not reached about either a ban on the devices or a reclassification to the more strictly controlled medical device Class III, the committee did not rule out a ban in the future. It also called for stronger warning labels and for women and their doctors to sign a consent form detailing the risks of power morcellators.
Hospitals Suspend Use of Power Morcellators
Since the FDA’s April safety communication, hospitals and gynecological groups have started to speak out and take a position on the matter. Two major hospitals in Boston, Brigham and Women’s and Massachusetts General, banned power morcellation in all hysterectomy and myomectomy procedures. The Cleveland Clinic has also ceased use of the devices. Some of these hospitals may resume power morcellation in the future pending further guidance from their internal review boards.
Robert L. Barbieri, MD, editor-in-chief of OBG Management and chair of obstetrics and gynecology at Brigham and Women’s Hospital, recently wrote about his concerns, stating:
Dispersion of benign myoma tissue may result in the growth of fibroids on the peritoneal surface, omentum, and bowel, causing abdominal and pelvic pain and necessitating reoperation. Dispersion of leiomyosarcoma tissue throughout the abdominal cavity may result in a Stage I cancer being upstaged to a Stage IV malignancy, requiring additional surgery and chemotherapy. In cases in which open power morcellation causes the upstaging of a leiomyosarcoma, the death rate is increased.
– Robert L. Barbieri, MD 6
Last February, before the FDA’s safety alert, Temple University Hospital announced that it would begin using isolation bags to prevent the dissemination of fibroid tissue during morcellation.
Enrique Hernandez, MD, Chair of the Temple University School of Medicine’s Department of Obstetrics, Gynecology and Reproductive Sciences, told the Philadelphia Inquirer that the hospital uses manual morcellation, cutting fibroid tissue with a scalpel after the tissue has been isolated within the bag. 7
Gynecological Groups Speak Out
Several gynecological groups have issued position statements on the subject of morcellation. The Society for Gynecologic Oncology (SGO) issued a statement in December of last year, prior to the FDA’s recommendations.
The Society of Gynecologic Oncology (SGO) asserts that morcellation is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery.
Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellation should be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini-laparotomy or morcellating the uterus inside a laparoscopic bag. 8
– Society for Gynecologic Oncology (SGO) statement
The SGO urges patient/doctor communication about the risks, benefits and alternatives so that the patient can make an informed and voluntary decision.
The American Congress of Obstetricians and Gynecologists issued a statement that it is “undertaking a thorough and deliberate review of the published scientific literature about power morcellation and malignancy in gynecologic surgery.” On May 9, the ACOG issued a special report profiling the use of power morcellation in gynecological surgery. 9
Finally, the leading association promoting minimally invasive gynecologic surgery, the American Association of Gynecologic Laparoscopists (AAGL), is reviewing the scientific evidence and best practices reported by their members to provide readily accessible, comprehensive information. The AAGL is encouraging their members to “fully research and understand the risks of power morcellation and to learn more about when alternative methods of tissue extraction may be appropriate.” 10
Preparing for a Hysterectomy or Myomectomy
The FDA recommends the following to women who may be considering hysterectomy or myomectomy:
- Ask your healthcare provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.
- If laparoscopic hysterectomy or myomectomy is recommended, ask your healthcare provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.
- If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their healthcare provider.
– FDA Safety Communication
Power Morcellator Market Withdrawal
In late July, Johnson & Johnson issued a worldwide voluntary market withdrawal, advising doctors to stop using power morcellators and return the devices. 11
Because of this uncertainty [surrounding the risks and benefits of power morcellators], Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.
– Ethicon letter
According to the company, this market withdrawal is not a recall because it is not related to the device functioning improperly.
In the wake of Ethicon’s announcement, some health insurers are beginning to halt coverage of power morcellation, citing the risks of the procedure. Highmark, a Blue Cross Blue Shield plan that covers more than 5 million people in Pennsylvania, Delaware and West Virginia, announced just days after the market withdrawal that it would stop covering power morcellation. Highmark had been examining power morcellation for several months before the announcement. 12
At the end of February 2015, another major health insurer changed its requirements regarding most types of hysterectomies. UnitedHealth Group Inc. now requires doctors to get prior authorization for all hysterectomies, except for those performed vaginally on an outpatient basis. This decision by the nation’s largest health insurer will more than likely have a direct impact on the use of power morcellators during hysterectomies; the tools are typically only used during laparoscopic or robotic hysterectomies. This new policy only includes hysterectomies that are not part of cancer treatment.
According to the Wall Street Journal (WSJ), “health plans covering about 93 million Americans have either curtailed use of morcellators or are considering limits.” As of May 15, Aetna no longer covers routine use of power morcellators. Doctors will be required to obtain prior approval to utilize the device in any procedure. 13
The WSJ also indicated that Health Care Service Corp., the fourth-largest U.S. insurer, has “proposed labeling power morcellation ‘not medically necessary’ starting June 1,” which means the procedure typically wouldn’t be eligible for coverage.” 14
FBI Investigating Laparoscopic Manufacturers
In late May 2015, it was reported by several news sources that the FBI is looking into what power morcellator manufacturers knew about their power morcellator devices and the potential for them to spread malignant tissue, potentially upstaging undetected cancer. At least one woman, Dr. Amy Reed, an anesthesiologist and vocal activist who experienced the spread of her cancer after undergoing a hysterectomy using a power morcellator, stated that the FBI contacted her after she reached out to them.